Diagnostics & Imaging Week

VivoMetrics’ (Ventura, California) by now well-known LifeShirt is being used in a study to help determine the effects of post-traumatic stress disorder (PTSD) on cardiologic response in young children and parents who were affected by the 9/11 terrorist attacks.

The LifeShirt will be used by the Mount Sinai School of Medicine‘s Child and Family Resilience Program and the Jewish Board of Family and Children’s Services’ Center for Trauma Program Innovation (both New York).

“I [think] the interesting thing about it is as far as we know this is the first study that’s going to be objectively gathering physiologic data during the mother-child interaction,” Elizabeth Gravatte, vice president of sales and marketing for VivoMetrics, told Diagnostics & Imaging Week.

The Center for Trauma Program Innovation is a specialized program designed to develop and implement programs for the treatment of traumatized children and youth served by New York City’s mental health and social service providers.

The decision to use the VivoMetrics LifeShirt came about by word-of-mouth, according to VivoMetrics’ Mark Durston, business development associate. The researcher doing the study is a colleague of a VivoMetrics customer, he said.

The LifeShirt, which has been used to test a variety of things from athletes’ performance to soldiers’ reactions on the battlefield, as well as those of civilian first responders, monitors respiratory and cardiopulmonary functions.

The shirt is non-invasive and continuously collects, records and analyzes a range of cardiopulmonary parameters, the company said. It is lightweight and has embedded sensors that collect pulmonary, cardiac, posture and activity signals. Data collected by integrated peripheral devices measure blood pressure, blood oxygen saturation, EEG/EOG, periodic leg movement, temperature, end tidal CO₂ and cough.

For the study with children and their mothers affected by 9/11, the researchers are looking at “heart rate variability, and in particular, a measurement called respiratory sinus arrhythmia,” Durston said. The study is expected to get under way by the end of 2005 after ethics considerations have been determined and continue for six months.

The criteria for the children and their mothers is determined by geography, i.e., they must have lived in southern Manhattan during the 9/11 terrorist attacks. The target age group is mothers and children ages 4 to 9. The planned research will be integrated into a larger, ongoing study of infants and toddlers within the same demographic, the company said.

The study’s three main objectives are to compare cardiac reactivity between trauma-exposed children with PTSD; compare cardiac reactivity between trauma-exposed mothers and those without; and determine whether maternal PTSD predicts child cardiac reactivity.

Mothers and their children will be observed in something like a playroom, and some of their activities will be mostly play and others will be more structured, Durston said. One of the situations that will be observed is when a child’s mother leaves the room and a stranger enters the room without the mother present, he said.

“Unfortunately, many children are struck by PTSD following a tragic event in their lives,” said VivoMetrics CEO Paul Kennedy in a statement.

Gravatte said it is expected that because the LifeShirt is worn easily and has sizes for everyone down to toddlers, it will promote ease of movement and will not be an inhibiting factor in the study.

“The LifeShirt is a completely ambulatory product,” she said. “It’s a lightweight garment that both the mother and child will wear. They can be in their normal environment, [and] they can move around during their normal activities of daily living.”

The expectation is that the children will forget that they are wearing the LifeShirt.

“Without the LifeShirt System, much of the proposed work would be impossible to complete,” said Claude Chemtob, PhD, of Mount Sinai School of Medicine, principal investigator of the study. “Our major concern was the fact that past studies measured children’s heart rates by using a monitor that was clipped to the earlobe. While basic vital signs could be measured, heart rate variability – a very significant factor in childhood PTSD – could not be recorded. The LifeShirt System gives us the ability to measure variability, giving us a better view of what is occurring upon exposure to set stimuli.”

VivoMetrics was founded in 1999, and its ambulatory monitoring devices are used by a variety of researchers, including pharmaceutical companies.